FDA 510(k) Application Details - K031612

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K031612
Device Name Lamp, Infrared, Therapeutic Heating
Applicant AVICENNA LASER TECHNOLOGY, INC.
1209 NORTH FLAGLER DRIVE
WEST PALM BEACH, FL 33401 US
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Contact BRUCE R COREN
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 05/22/2003
Decision Date 12/11/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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